Casirivimab + Imdevimab Baseball Cards

REGEN-COV^TM (casirivimab (REGN10933) and imdevimab (REGN10987))

Dose Pack for 1 patient course

MUST ADMINISTER casirivimab and imdevimab together

Manufacturer: Regeneron Pharmaceuticals, Inc.

Distributor: AmerisourceBergen (a.k.a. ABC); c19therapies@amerisourcebergen.com

Product: 2-drug monoclonal antibody cocktail for outpatient infusion

Emergency Use Authorization (EUA): 11/21/2020

Units: Supplied in 4 different Dose Packs, which contain the total number of vials of each antibody required to constitute one full patient course.

Imdevimab 1332 mg/11.1 ml carton	Casirivimab 1332 mg/11.1 ml carton
Imdevimab 300 mg/2.5 ml carton	Casirivmab 300 mg/2.5 ml carton

Storage: Keep in carton until use. Unopened vials must be stored at refrigerated temperature (2oC–8oC/ 36°F–46°F) until use. Do not freeze, shake, or expose to direct light.

Earliest Expiration Date of Units Shipped: 06/2022

Dimension of a Single Dose Pack w/ Re-closable Bag: 12” x 15" x 2 (approx)"
Dimensions of Manufacturer's Case of Dose Pack w/ Case: 12”(d) x 12”(w) x 12”(h)

Dose Pack Information

Please note that each REGEN-COV dose pack contains the exact number of vials of casirivimab (REGN10933) and imdevimab (REGN10987) to prepare ONE patient course of treatment.

Dose Pack Component	Dose Pack Label	Dose Pack Packaging
NDC: 61755-035-02 Dose-Pack Size:  2 Cartons 1 vial of casirivimab (1332mg/ 11.1mL) 1 vial of imdevimab (1332 mg/ 11.1 mL)
NDC: 61755-036-08 Dose Pack Size: 8 cartons 4 vials of casirivimab (300 mg/ 2.5 mL) 4 vials of imdevimab (300 mg/ 2.5 mL)
NDC: 61755-037-05 Dose Pack Size: 5 cartons 1 vial of casirivimab (1332mg/ 11.1 mL) 4 vials of imdevimab (300mg/ 2.5 mL)
NDC: 61755-038-05 Dose Pack Size: 5 cartons 4 vials of casirivimab antibody 300mg/ 2.5mL 1 vial of imdevimab antibody; 1332mg/ 11.1mL

Individual Components:

Some sites may still have casirivimab and imdevimab on hand that were initially shipped as separate units for each component (i.e., non-dose pack).

Casirivimab (REGN10933) Injection (120 mg/ml)

MUST ADMINISTER WITH IMDEVIMAB (REGN10987)

Product: Single component of 2-drug monoclonal antibody cocktail for outpatient infusion

Units: Supplied in 2 volumes

• 1332 mg/11.1 ml single-dose vial in carton (10 ml from 1 vial needed for patient course)
• 300 mg/2.5 ml single-dose vials in cartons (10 ml; 2.5 ml from each of 4 vials needed for patient course)

Example: Casirivimab 1332 mg/11.1 ml carton

Example: Casirivmab 300 mg/2.5 ml carton

Dimensions of Single Vial in Carton: 1.7”(d) x 1.8”(w) x 2.8”(h)
Weight of a Single Vial in Carton: 1.5 oz. for 1332 mg/11.1 mL vial; 0.9 oz. for 300 mg/2.5 mL vial

Case: A full case contains 24 vials in cartons
Case Dimensions: 9.6”(d) x 7.4”(w) x 4.6”(h)
Case Weight: 2.7 lb. for 1332mg/11.1 mL vials; 1.8 lb. for 300 mg/2.5 mL vials

Imdevimab (REGN10987) Injection (120 mg/ml)

MUST ADMINISTER WITH CASIRIVIMAB (REGN10933)

Product: Single component of 2-drug monoclonal antibody cocktail for outpatient infusion

Units: Supplied in 2 volumes

• 1332 mg/11.1 ml single-dose vial in carton (10 ml from 1 vial needed for patient course)
• 300 mg/2.5 ml single-dose vials in cartons (10 ml; 2.5 ml from each of 4 vials needed for patient course)
  

Example: 1332 mg/ 11.1 ml carton

Example: 300 mg/2.5 ml carton

Storage: Keep in carton until use. Unopened vials must be stored at refrigerated temperature (2oC–8oC/36°F–46°F) until use. Do not freeze, shake, or expose to direct light.

Dimensions ofa Single Vial in Carton: 1.7”(d) x 1.8”(w) x 2.8”(h)
Weight of a Single Vial in Carton: 1.5 oz. for 1332 mg/11.1 mL vial; 0.9 oz. for 300 mg/2.5 mL vial prior to administration.

Administration:

For detailed guidelines, see "Fact Sheet for Health Care Providers Emergency Use Authorization (EUA) of REGEN-COVTM (casirivimab with imdevimab)"

Casirivimab and Imdevimab 2,400 mg Dose ^a, Add:

• 10 mL of casirivimab (use 1 vial of 11.1 mL OR 4 vials and
• 10 mL of imdevimab (use 1 vial of 11.1 mL OR 4 vials of 2.5 mL) of 2.5 mL) for a total of 20 mL into a prefilled 0.9% sodium chloride infusion bag and administer as instructed below ^b

Note: If immediate administration is not possible, store the diluted casirivimab with imdevimab infusion solution in the refrigerator between 2°C to 8°C (36°F to 46°F) for no more than 36 hours or at room temperature up to 25°C (77°F) for no more than 4 hours. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 30 minutes prior to administration

Resources/Links:

Regeneron webpage, including:

• FDA Letter of Authorization
• Fact Sheet for Healthcare Providers
• Fact Sheet for Patients and Caregivers (English)
• Fact Sheet for Patients and Caregivers (Spanish)
• FDA Frequently Asked Questions on the EUA for Casirivimab + Imdevimab

^a 1,200 mg casirivimab and 1,200 mg imdevimab are added to the same infusion bag and administered together as a single intravenous infusion.

^b After infusion is complete, flush with 0.9% Sodium Chloride Injection.

^c The minimum infusion time for patients administered casirivimab with imdevimab together using the 50 mL prefilled 0.9% Sodium Chloride infusion bag must be at least 20 minutes to ensure safe use.